Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward

Article Pharmacology & Pharmacy

Comparison of the registration process of the medicines control authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: benchmarking best practices

Tariro Sithole et al.

Summary: Comparing the Medicines Control Authority of Zimbabwe with other regulatory bodies revealed that while the MCAZ lags behind in resources, it conforms to international best practices in review processes. Opportunities for improvement lie in transparency and communication, but overall, the MCAZ has the potential to become a leading regulatory authority in Africa.

EXPERT REVIEW OF CLINICAL PHARMACOLOGY (2022)

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Review Pharmacology & Pharmacy

South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access

Andrea Keyter et al.

Summary: This study compared the regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to those achieved by the historic Medicines Control Council (MCC), showing that approval times were 68% quicker in the backlog process stream. The implementation of facilitated regulatory pathways for new chemical entities and generics led to a decrease in overall median approval times, demonstrating the improvements made by SAHPRA in addressing the backlog in market authorization applications. Expanding these processes into routine review of medical products is expected to enhance SAHPRA's regulatory performance and improve patient access to new medicines.

FRONTIERS IN PHARMACOLOGY (2021)

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Review Medicine, General & Internal

Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

Tariro Sithole et al.

Summary: Regulatory reliance, harmonization, and work sharing have led to greater sharing of work and information among regulators in Africa. Despite the success of initiatives like ZaZiBoNa, challenges remain in terms of lack of clear information on registration processes and lengthy registration times. A study comparing data requirements, review models, and approval timelines of six African countries identified variations in approval times, review models, and targets for milestones, highlighting the need for improved cooperation and alignment among regulators.

FRONTIERS IN MEDICINE (2021)

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Article Health Policy & Services

Establishment of the African Medicines Agency: progress, challenges and regulatory readiness

Bakani Mark Ncube et al.

Summary: The inadequate access to quality medical products in Africa has been a major public health challenge due to weak regulatory systems and lack of competent professionals. The African Medicines Regulatory Harmonisation initiative aims to expedite market authorization and align national legislative frameworks. The establishment of the African Medicines Agency (AMA) is proposed to coordinate regional harmonization efforts and address gaps in national legislation.

JOURNAL OF PHARMACEUTICAL POLICY AND PRACTICE (2021)

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Article Pharmacology & Pharmacy